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OpenTrials
Completed

NCT Number: NCT00539851

Risk Factors for Diabetes After Stem Cell Transplantation

This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

Allogenic stem cell transplantation from related or unrelated donors has been used successfully to cure patients with a variety of hematological malignancies. Graft-versus-host disease (GVHD) is an alloreactive immune phenomenon, where the activated donor T cells recognizes the recipient as being foreign and effects a cytotoxic response. GVHD occurring in the first 100 days after transplantation is termed acute GVHD and is characterized by hepatitis, dermatitis, and enteritis.

High dose corticosteroids remain one of the cornerstone therapies to treat acute GVHD. However, an association between corticosteroid therapy and the development of diabetes mellitus after solid organ transplantation has become widely recognized. Similarly, post transplant diabetes mellitus (PTDM) has been increasingly noted in the allogenic stem cell transplant population, however, to date, no systematic study has been completed to identify the incidence of PTDM and associated risk factors. We propose to investigate the incidence of PTDM as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 65 years or age
  • Fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at VUMC

Exclusion criteria

  • Younger than 18 years or older than 65 years
  • Pre-existing diabetes mellitus
  • Positive pregnancy test
  • Unable to complete the conditioning regimen prior to stem cell transplantation
  • Unable to give informed consent

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Sanofi

Registry information

Official study title

Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Oct 5, 2007
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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